Madrigal Pharmaceuticals announced positive results from the Phase 3 MAESTRO-NAFLD-1 trial of their drug Rezdiffra, focusing on patients with compensated metabolic dysfunction-associated ...
Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”) The Rezdiffra prescribing information does not include a liver biopsy requirement ...
Positive recommendation based on resmetirom’s favorable profile including positive results from the pivotal Phase 3 MAESTRO-NASH trial European Commission decision expected in August 2025; if approved ...
Patients in the Phase 3 MAESTRO-NAFLD-1 trial achieved a statistically significant mean reduction of 6.7 kPa in liver stiffness, the largest reported in compensated MASH cirrhosis populations. 51% of ...
Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works. Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help ...
In March 2024, the US Food and Drug Administration (FDA) granted accelerated approval to Rezdiffra™ (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic ...
Late-breaking results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial presented at the EASL Congress 65% of patients with clinically significant portal ...
Rezdiffra is expected to be available to patients in the U.S. in April and will be distributed through a limited specialty pharmacy network. Madrigal is committed to helping appropriate patients who ...